Active not recruitingPHASE3INTERVENTIONAL

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

This research study is looking at a new drug called pirtobrutinib for people who have just been diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and haven't had treatment before. The study wants to compare pirtobrutinib with a common treatment of two medicines, bendamustine and rituximab. Doctors want to find out if pirtobrutinib is more effective and has fewer side effects than the usual treatment. Taking part could last up to five years, and it's a way to help doctors understand the best ways to treat these conditions in the future.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Loxo Oncology, Inc.

Enrolment target

309

Start

23 Sep 2021

Estimated completion

01 Oct 2027

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

What is this study about?

This study is for people who have been diagnosed with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). These are types of slow-growing cancers that affect white blood cells called lymphocytes. If you've just found out you have one of these conditions and haven't started treatment yet, this study might be for you.

The main goal of this research is to compare a new medicine, pirtobrutinib, with a standard treatment that involves two other medicines, bendamustine and rituximab. Doctors want to see if the new medicine works better, is safer, or has different side effects compared to the established treatment. This kind of research is very important because it helps us find new and potentially better ways to treat serious illnesses.

By joining this study, you would either receive the new medicine or the standard combination treatment. Neither you nor your doctor would choose which treatment you get; it would be decided by chance, like flipping a coin. This helps make sure the comparison between the two treatments is fair and reliable. The study could involve regular check-ups and taking medication for up to five years, to carefully monitor how you respond to the treatment.

Key takeaways

This study compares a new drug (pirtobrutinib) to standard treatment for newly diagnosed CLL/SLL.
It aims to find out if the new drug is safer or more effective.
Participation involves regular visits and lasts up to five years.
You would receive either the new drug or standard treatment, chosen by chance.
It’s for people who haven't had treatment for CLL/SLL before.
You can stop participating at any time.

Who may be eligible?

To be able to take part in this study, you must have been officially diagnosed with CLL or SLL and need treatment, but you haven't started any yet. Your general health needs to be reasonably good, meaning your body is working well enough to handle new medicines. Doctors will check various things about your health, including how well your liver and kidneys are working, and the levels of certain cells in your blood.

There are also some reasons why you might not be able to join. For example, if you have a known problem called Richter's transformation, or if your cancer affects your brain or spinal cord. Also, if you have certain heart problems, active infections like hepatitis, or HIV, or if you're taking specific medications, you might not be eligible. If you've had a live vaccine recently or have severe allergies to any of the study drugs, you also wouldn't be able to participate. This is all to make sure the study is as safe as possible for everyone involved.

Quick self-check

I have been diagnosed with CLL or SLL and need treatment.
I have not received any prior treatment for my CLL/SLL.
My general health is quite good, and I don't have major heart or kidney problems.
I do not have certain active infections like hepatitis, or HIV.
I am not allergic to the medications being tested.
I haven't had a live vaccine in the last month.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, your journey could last up to five years. You'll have regular appointments with the study team. At these visits, doctors will perform physical examinations, take blood and urine samples, and ask you about any side effects or changes in how you're feeling. You'll receive either the new study drug (pirtobrutinib) or the standard treatment (bendamustine and rituximab) as directed by the study plan. The medical team will closely monitor you to see how your body responds to the treatment and to manage any side effects. You'll receive all study-related treatments and tests at no cost.

Potential risks and benefits

Taking part in this study might offer the benefit of receiving a new, potentially effective treatment before it's widely available. The study also helps advance medical knowledge, benefiting others in the future. However, there are potential risks, as with any medication, including side effects from both the new drug and the standard treatment. These can vary from mild to severe, though serious side effects are rare. All possible side effects will be explained to you in detail. Remember, your participation is completely voluntary, and you can withdraw from the study at any time for any reason, without affecting your future medical care.

Locations (108)

California Research Institute
Los Angeles, United States
Innovative Clinical Research Institute
Whittier, United States
Oncology-Hematology Associates of West Broward
Coral Springs, United States
New Jersey Center for Cancer Research
Brick, United States
Clinical Research Alliance, Inc.
Westbury, United States
Liverpool Hospital
Liverpool, Australia
Westmead Hospital
Wentworthville, Australia
Peninsula Private Hospital
Frankston, Australia
Uniklinikum Salzburg
Salzburg, Austria
Klinik Ottakring
Vienna, Austria
Hospital de Clinicas de Porto Alegre
Porto Alegre, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil

+96 more sites — see the official record for the full list.

Common questions

What is CLL/SLL?

CLL (Chronic Lymphocytic Leukemia) and SLL (Small Lymphocytic Lymphoma) are slow-growing cancers that affect a type of white blood cell called lymphocytes, which are part of your immune system.

What is 'untreated' in this study?

Untreated means you have been newly diagnosed with CLL or SLL and have not yet received any medication or treatment for these conditions.

What is a 'Phase 3' study?

A Phase 3 study is a large study that compares a new treatment with the best existing treatment. It helps confirm if the new treatment is better or safer before it can become widely available.

Will I know which treatment I'm getting?

No, you won't know initially. The treatment you receive (either pirtobrutinib or bendamustine plus rituximab) will be chosen by chance, like a lottery. This helps ensure the results are fair.

How long will I be in the study?

Your involvement in the study could last for up to five years, with regular check-ups and monitoring by the study team.